FGF-23 Suppressibility by Calcitonin
Information source: Rijnstate Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypophosphatemia
Intervention: Calcitonin (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Rijnstate Hospital Overall contact:
Hans Boer de, MD, PhD, Phone: 31-2-6378-8888, Email: hdeboer@alysis.nl
Summary
Introduction:
Based on our experience with calcitonin as an FGF-23 suppressive agent in a patient with an
FGF-23 producing tumor we hypothesize that calcitonin may be a physiologically important
regulator of FGF-23 production and secretion in healthy humans.
Aim:
In this study we wish to examine the FGF-23 suppressive effects of calcitonin in healthy
men.
Study Design:
placebo-controlled, cross-over study
Method:
- All twelve subjects are examined on two occasions, once after exposure to placebo 1 ml
NaCl 0. 9% subcutaneously, and once following calcitonin 200 IU/ml subcutaneously
- On both occasions frequent bloodsampling will take place, out an indwelling catheter in
de forearm vein.
- Sampling times: -15, 0, 60, 120, 240, 360, and 480 minutes
- Mealtimes: Calcium and Phosphate intake standardized on both occasions
- All samples are analyzed for FGF-23, using a C-terminal FGF-23 ELISA kit (Immunotopics,
San Clemente, USA) that measures intact and C-terminal fragments of FGF-23, and one that
measures only intact FGF-23
- Samples obtained at T-15, T0, T240 and T480 are stored for later analysis of Ca,
albumin, PO4, PTH, 25-OHD and 1,25-OHD
Endpoint:
A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of
calcitonin 200 IU.
Clinical Details
Official title: Evaluation of FGF-23 Suppressibility by Calcitonin in Healthy Men - Pilot Study
Study design: Basic Science, Non-Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: A change of 25% in de serum FGF-23 levels in response to a single subcutaneous injection of calcitonin 200 IU.
Eligibility
Minimum age: 20 Years.
Maximum age: 55 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Healthy man, who are between 20-55 years old, and have a BMI 20-27 kg/m2.
Exclusion Criteria:
- Serum creatinin >100 mmol/L, or glomerular filtration rate <80 ml/min.
- Abnormal serum Ca, PO4, albumin, 25-OH vitamin D, or PTH levels.
- Any medication.
Locations and Contacts
Hans Boer de, MD, PhD, Phone: 31-2-6378-8888, Email: hdeboer@alysis.nl
Rijnstate Hospital, Arnhem, Gelderland, Netherlands; Recruiting
Hans Boer de, MD, PhD, Principal Investigator
Additional Information
Starting date: May 2008
Last updated: May 30, 2008
|
